Issues to Monitor

While Komen plans to focus our advocacy efforts around the 2015 Advocacy Priorities, selected during our annual issue selection process, we are aware there are numerous additional policy initiatives that impact those we represent. Komen will monitor these issues throughout the year and take action when necessary.

Expansion of Eligibility for the Breast and Cervical Cancer Prevention and Treatment Act (BCCPTA)

Over sixty-two million people are currently covered by Medicaid, the largest health insurance program in the United States. Currently, all states extend full Medicaid coverage for the treatment of breast cancer to uninsured women diagnosed through the Centers for Disease Control and Prevention's (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCEDP). Women qualify for Medicaid under NBCCEDP if they are uninsured, under the age of 65, in need of treatment for breast or cervical cancer, and if their screening is conducted in a state-administered program funded by the Centers for Disease Prevention and Control (CDC).

However, states have discretion in their determination of eligibility requirements. States have adopted three different standards of eligibility requirements: in twenty states and the District of Columbia a woman will be considered screened where NBCCEDP funds pay for all or part of the costs of her screening; in fourteen states, a woman will be eligible if her provider receives NBCCEDP funds and the services were within the scope of the NBCCEDP grant; and in sixteen states, a woman is considered eligible regardless of where she was screened as long as she meets the rest of the eligibility criteria.

Komen supports the least restrictive of these options, which affords Medicaid to all uninsured women under the age of 65 who are in need of treatment for breast or cervical cancer. Due to funding restrictions, fewer than sixteen percent of women can be screened by NBCCEDP funded programs. Consequently, continued advocacy on the state level to adopt the least restrictive Medicaid requirements will promote greater access to services and affordability of care.

Breast Density

Dense breast tissue, which includes a lot of connective tissue but lacks fatty tissue, can be seen by review of an individual’s mammogram. Radiologists use mammograms to determine a patient’s breast density. The scale used to determine a woman’s density ranges from “least dense,” which is mostly made up of fatty tissue, to “most dense” which is made up of mostly connective tissue. It is particularly difficult to see cancer and tumors on mammograms of women with high breast density. Since connective tissue appears on mammograms in white, the same color that tumors appear, it is more difficult to see cancer or tumors on mammograms of women with dense breasts. Women with a lot of dense breast tissue are at a higher risk for developing cancer, although breast density is only one of many factors that affect a woman’s individual breast cancer risk.

Federally, there is legislation that would require providers and patients to be notified of a patient’s breast density by the facilities performing mammograms. This legislation, called the Breast Density and Mammography Reporting Act would also encourage increased communication between patients and providers about a patient’s options, once her breast density has been determined. The bill would also require increased research into breast density.

Compassionate Use

The Food and Drug Administration (FDA) uses a complex and time-consuming approach when approving drugs in order to ensure that all drugs are safe and effective for patient use. The “compassionate use exemption” was created to allow patients in dire health circumstances to access unapproved drugs in various stages of the drug pipeline. Terminally ill cancer patients most commonly access unapproved drugs through the compassionate use program.

In order for a patient to be able to access an unapproved drug using compassionate use, the pharmaceutical company must agree to participate, a provider must be willing to oversee the use of these drugs or treatments and the FDA must approve the request. The patient must also meet a series of criteria required by Federal law such as the patient has exhausted all other treatment options and clinical trial opportunities and the potential benefit outweighs the risk.

Some states are currently trying to make it easier for patients to access unapproved drugs by enacting “right to try” laws. These laws allow physicians, patients, and pharmaceutical companies to collaborate to give patients access to unapproved drugs without involving the FDA. These laws do not require pharmaceutical companies to provide patients access to their unapproved drugs. However, if industry, providers, and patients agree to early access to the treatment, the laws allow them to bypass federal oversight.

Genetic Testing and Breast Cancer

Cancer results from changes in a cell’s genetic makeup that causes that cell to grow uncontrolled. Recent advances in the understanding of the genetic changes that lead to cancer have provided new opportunities for the targeted treatment of breast cancer and the ability to identify those with greater risk of developing breast cancer. This has led to improved treatment outcomes and opportunities for preventing or detecting cancer early in women with a higher risk of breast cancer.

The Affordable Care Act (ACA) requires non-grandfathered group plans and health insurance coverage offered in the individual or group market to provide coverage without cost-sharing for all recommendations made by the USPSTF with a grade A or B rating. This means that insurance companies must cover 100% of the cost of genetic counseling and testing for mutations in the BRCA genes for women with a strong family history of breast, ovarian, tubal, or peritoneal cancers.

Health Disparities

According to both the Centers for Disease Control and
Prevention (CDC) and the National Cancer Institute (NCI) at the National
Institute of Health (NIH), although white women have the highest breast cancer
incidence rate, African-American women have the highest morbidity across all
races and are 40 percent more likely to die due to breast cancer than are white
women. Contributing factors to these statistics include a lack of access
to high-quality treatment, decreased prevalence of follow-up care and
treatment, and more persistent and faster-growing cancers. Women who live
in rural areas are affected by reduced access to primary care and specialized
physician services, which can result in lower rates of early-stage detection
and, consequently, higher morbidity and mortality rates.

The U.S. Public Health Service administers a number of
programs designed to address cancer health disparities, defined as differences
in the incidence, prevalence, mortality and burden of cancer and related adverse
health conditions that exist among specific population groups in the United
States. Many different populations are affected by disparities, including
racial and ethnic minorities, residents of rural areas, women, children, the
elderly and persons with disabilities.

Lymphedema

Lymphedema is swelling of the arms or legs that may occur following the removal of an individual’s lymph nodes during cancer treatment. Lymphedema is caused by blockages in the lymphatic system, which prevent lymph fluid from draining and may cause enormous swelling in affected limbs. Although there is presently no cure for lymphedema, it can be managed if a patient is diagnosed early. Untreated lymphedema may result in infection, disfigurement, disability, or even in death. Although an estimated three to five million Americans are presently living with lymphedema, it is often misdiagnosed or undiagnosed in patients.

The current standard of care for lymphedema involves a four-part treatment called Complete Decongestive Therapy (CDT). Presently many private insurers, Medicaid, and Medicare do not cover compression supplies, one of the four essential elements of CDT. Federally, the Lymphedema Treatment Act seeks to amend the Medicare statute in order to cover compression supplies. If passed, this legislation will set a precedent for private insurers and for Medicaid to initiate coverage for lymphedema treatment.

Metastatic Breast Cancer

Metastatic breast cancer (MBC), or
stage 4 breast cancer, is breast cancer that has spread to other parts of the
body (metastasizing). Although metastatic breast
cancer has spread, it is considered and treated as breast cancer. While
some individuals have metastatic disease when they are first diagnosed, it is
more common in the U.S. that metastatic breast cancer arises months or years
after a person has completed treatment for early or locally advanced (stage I, II
or III) breast cancer. The risk of breast cancer returning and metastasizing
varies greatly from person to person. Tragically, despite the overall drop in
cancer mortality rates in recent years, an estimated 40,000 people are dying of
MBC every year.

Komen was one of the fifteen
founding members of the Metastatic Breast Cancer Alliance (MBCA), founded in
2013, which has now grown to nearly thirty organizations. The Alliance unifies the
efforts of its members to improve the lives of and outcomes for those living
with metastatic breast cancer and their families through increasing awareness
and education about the disease and advancing policy and strategic coordination
of research funding specifically focused on metastasis that has the potential
to extend life, enhance quality of life and ultimately to cure.

Palliative Care

Palliative care seeks to relieve or prevent symptoms associated with a disease or its treatment, such as pain, fatigue, anxiety or depression. Palliative care addresses symptoms, rather than control of the cancer itself. While palliative care is part of treatment of all phases of breast cancer, it is especially important for those with metastatic breast cancer.

There is growing recognition of the value of palliative care, and likewise growing insurance coverage for these services. But, additional policies can be considered to support expanded access to palliative care services.

Survivorship

Survivorship refers to the millions who are
living with, through and beyond a cancer diagnosis. Breast cancer survivors are
at risk for cancer recurrence or metastasis (the spread of cancer to another
part of the body). Because of this increased risk, cancer survivors should have
frequent checkups to ensure that they are continuing on the road to
health and recovery.

There are several pieces of legislation aimed at providing
access to and reimbursement for survivorship.

To share your story or for additional information, please contact us at policy@komen.org.